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Health·P Space·Evidence-backed problem·Published 2026-07-12

Linq ii¿ insertable cardiac monitor: FDA malfunction report involving AI

The FDA received a malfunction report involving Linq ii¿ insertable cardiac monitor, made by Medtronic singapore operations. It was reported that true pause episodes were rejected as false by the artificial intelligence (ai) algorithm. it was further reported that the implantable cardiac monitor (icm) detected false ventricular tachycardia (vt) episodes. the icm remains in use. no patient complications have been reported as a result of this event.

TRV-2026-0039Official statisticsPermanent record — cite & verify
Linq ii¿ insertable cardiac monitor: FDA malfunction report involving AI

"Onassis Cardiac Surgery Center, Athens, Greece" by Tilemahos Efthimiadis is licensed under CC BY 2.0. To view a copy of this license, visit https://creativecommons.org/licenses/by/2.0/.

Main points
  • Device: Linq ii¿ insertable cardiac monitor; manufacturer: Medtronic singapore operations.
  • FDA report type: Malfunction.
  • An adverse-event report is a safety signal, not proof that the device caused the event.
Problem

An FDA adverse-event report linked Linq ii¿ insertable cardiac monitor to an AI-related malfunction; the report requires investigation and does not by itself establish causality.

The rundown

It was reported that true pause episodes were rejected as false by the artificial intelligence (ai) algorithm. it was further reported that the implantable cardiac monitor (icm) detected false ventricular tachycardia (vt) episodes. the icm remains in use. no patient complications have been reported as a result of this event.

The report is part of FDA’s MAUDE surveillance data. It should be read as a signal for follow-up, not a clinical conclusion or a verified incidence rate.

Sources

The debate